View Single Post
Old 01-14-2010, 09:26 AM
Debi Brooks Debi Brooks is offline
Member
 
Join Date: Feb 2009
Posts: 312
15 yr Member
Debi Brooks Debi Brooks is offline
Member
 
Join Date: Feb 2009
Posts: 312
15 yr Member
Default Clarification on MJFF scale efforts

Our recent awards are focused on validating dyskinesia scales, as Robert mentioned. We believe this to be critical and timely given there are ~ 6 phase II trials underway (some of which we supported in their pre-clinical stages) and yet we lack a validated scale.

Lack of validated scales can translate into a non-starter from a regulatory perspective. Our goal is to provide clarity by assessing the various informal measures used today and then drive the effort validate the most informative one. If successful, this would not only pave the way for drugs currently approaching regulatory approval, but hopefully encourage companies with pipeline compounds that havent' sought approval due to lack of a clear regulatory pathway. This kind of practical investment (led by a "neutral" party in the eyes of regulators -- like MJFF rather than a pharma company) facilitates real progress. A robust pipeliine of potentially exciting new symptomatic drugs can actually get to patients rather than languish in the clinical/regulatory malaise.

Read more here: http://michaeljfox.org/research_MJFF...s_3.cfm?ID=600

Debi
Debi Brooks is offline   Reply With QuoteReply With Quote
"Thanks for this!" says:
pegleg (01-14-2010), soccertese (09-07-2010)